Page 22 - Strategies for non-invasive managementof high-grade cervical intraepithelial neoplasia - prognostic biomarkers and immunotherapy Margot Maria Koeneman

Chapter 1
2. Assessment of clinical applicability of imiquimod cream as a treatment modality for high- grade CIN.
For this purpose, we assessed the knowledge, experiences and attitudes of physicians regarding imiquimod treatment of high-grade CIN and the preferences of CIN patients for either surgical treatment or imiquimod treatment. The results of these studies are presented in chapter 7 and 8. Chapter 9 contains the study protocol of the TOPical Imiquimod treatment of high-grade CIN (TOPIC) trial. This randomized controlled trial was designed to assess short and long-term efficacy of imiquimod treatment in high-grade CIN, as well as side effects and quality of life associated with the treatment modality, comparing imiquimod treatment to conventional treatment by LLETZ. Due to lagging inclusions, the study was prematurely terminated and converted to a non- randomized trial, in which patients could choose the treatment modality of their preference. Details as to the termination of the study are described in the same chapter. The adjusted, non- randomized, study (TOPIC-3) is currently running in three centers in the Netherlands. All 120 women have been included at the time of writing. The first study results are expected in the spring of 2019.
Taken together, the studies in this thesis aim to provide a basis for alternative strategies in the treatment of high-grade CIN, with a focus on observational management of women with a high probability of disease regression and non-surgical treatment with imiquimod for women who prefer this above surgical treatment.
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